How to Write Validation Master Plan
Introduction
A Validation Master Plan often abbreviated as the VMP provides an extensive description of the principles that are related to the qualification of a particular facility. It defines which systems and areas need validation and provides a comprehensive plan of how to become, and remain, a qualified facility. In other words, the VMP simply translates the validation strategy down to its core. With respect to this GMP compliance, this document is a very crucial piece of the system used in the pharmaceutical industry for the deliberate analysis of validation projects in the system.
The VMP document helps to prove that all systems, equipment and processes work as required with reference to validation based on standard approved protocols. These documents may be referred documented by their functional area such as Software Master Plan or Site Validation Master Plan since these documents may serve specific purpose of validation framework only. The role of a VMP cannot be overemphasized especially for purposes of inspection by the FDA. These plans are reviewed by the inspectors to establish if a particular facility has a proper and reasonable validation strategy. Therefore, a VMP needs to justify why a specific system has been incorporated or excluded in a validation plan & needs to originate from risk evaluation.
The Validation Master Plan is the starting source and operates as a base where all of the details are provided, including the name of the company, its location, and any subsidiaries if any. To do this we need to define the industry that the company belongs to and make a reference to the existing quality assurance policy. Also, there can be a signature confirmation to ensure travelers avail the intended VMPs, and ensure that they acknowledge having signed it by signing the document. The scope of the VMP is aimed at offering a wide outlook of a company validation range, which features whether it covers one or more products, the installations of new equipment and the condition of existing installations. A clear description of the facility is also required including number of floors, ago of building, measures taken for isolation, and peculiarities of floor surfaces affecting product quality. Additionally, issues such as material procurement, people mobility and waste disposal remain key in relation to avoidance of cross contamination. The process of developing a detailed VMP optimized for the pharmaceutical industry is given as under.
1. Knowledge about the regulations and norms of the machine learning industry
Before you start doing the VMP you need to know what are the applicable laws however what better practices for your product or process. US Food and Drug Administration (FDA), European Medicines Agency (EMA) and International Council for Harmonization (ICH) are the first line of regulatory organizations for the pharmaceutical companies. The ICH guidelines are quality, safety and efficacy compiled guidelines which have been synchronized by the regulatory bodies of United States, Europe, and Japan.
For instance, the ICH Q7A, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, specifies the expected validation of a manufacturing process. Likewise, the ICH Q2 – Analytical procedures and the ICH Q14 – Analytical method validation contain the recommendations concerning the analytical methods and procedures validation. Make sure that you get to know with these requirements as a way of ensuring that you know the practices that are acceptable when it comes to your product or process.
2. Scope and purpose of the VMP
At the end of your document, provide a clear on paper of the scope and purpose of the VMP. VMP scope should define the products and processes within the scope of products, systems and facilities. For instance, the VMP may be developed for a particular manufacturing procedure, software application or an entire complex. The scope of the VMP should be as follows: The VMP should indicate the purpose of the procedure and record; this may include to facilitate compliance with the relevant regulatory requirements, as well as to provide evidence of the suitability of a product or process; and as a reference for other validation activities.
3. VMP contents
A comprehensive VMP should contain the following sections:
1. Introduction
2. Scope and Purpose
3. Validation Policy
4. Data Use Master Plan: An introduction
5. Validation Process
6. Validation Lifecycle
7. Change Control is the management of change and alterations that take place to project. Documentation is the written record of all the project activities used for future reference.
8. Training and Communication
9. The task that would be of significant interest would be Quality Assurance and Regulatory Compliance.
10. Risk Management
11. Resources
12. Approval and Review
13. Appendices
a) Validation Policy:
This section should include the company’s validation policy statement, including details of validation activities, team member responsibility roles and action to take if validation policy is not adhered to.
b) Validation Master Plan Development:
Discuss how the VMP is created, how the form of input from different stakeholders solicited and gathered, how risks related to the VMP are evaluated and assessed, and how the VMP is revisited and approved.
c) Validation Process:
Define the different aspects of validation (design, installation, operation and maintenance) and explain how these are achieved for your product or process.
d) Validation Lifecycle:
Explain that the validation activities are performed at each stage of a product or a process development including the further lifecycle stages.
e) Change Control and Documentation:
Describe how modification of the product, process or VMP are managed and recorded, how approval and impact assessment are made.
f) Training and Communication:
Explain the training and communication procedure for validation personnel and show how it is communicated to adequate stake holders and how records are kept.
g) Quality Assurance and Regulatory Compliance:
Describe the QA activities and the regulatory measures taken into the process of validation (review, Audit and inspection).
h) Risk Management:
Describe how risks are cognitively defined, evaluated and mitigated through validation with reference to the risk assessment tools and techniques.
i) Resources:
It identifies and specifies which resources are included in the VMP: people, tools, technology, place and so on.
j) Approval and Review:
Explain how and by whom the VMP is approved and reviewed; who is involved in validation; how approval authorities work and how the documented VMP is updated.
k) Appendices:
The supporting documents would also be any regulatory compliance documents that control the working of the VMP, SOPs, validation reports, etc.
4. Validation approach
Based on the activity and regulatory requirements, industry standards as well as best practices, explain the validation approach about your specific product or process. This includes; defining the validation levels, validation types and Validation life cycle stages, the validation acceptance criteria. For example, the validation strategy for manufacturing process may, design of experiments (DOE), process analytical technology (PAT), and continuous improvement; whereas, validation approach for analytical method may include method development, method validation, and method transfer.
5. VMP review and approval
After the VMP is written, discuss it together with the people who need to know it, including the Regulation Affairs, Quality Assurance, and process owners. It is important to get the opinion and suggestion regarding the extent, feasibility and compliance of VMP. After your analysis and your reinforcement of the VMP, forward it to the approval authority (e.g. quality head or validation steering committee).
6. Executive and sustainment
The final step for developed VMP is to implement, control and update the plan after it has been approved. Another element is routine checking and updating of the VMP, taking account of changes in regulation, industry requirements and practice. You oversee validation work, and manage issues or changes as they arise.
Conclusion
Validated master plan itself needs to be preferably well written for taking care of the ends of avoiding or conforming to the regulatory requirements, and for maintaining the quality, reliability and safety of the pharmaceutical products. As a guide to writing VMP for the pharmaceutical industry, this document has enlightened the reader fully. If all the steps mentioned above were used, and the key aspects highlighted above were incorporated, then it is possible to design a sound and efficient VMP to achieve organizational success in the validation process.